(84 days)
The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
The IMMIX™ Thin Film is manufactured using poly(D,L-lactide-coglycolide) polymer and will be provided in sheets of 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.
The thickness of the IMMX™ Thin Film will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
The provided document describes a medical device called IMMIX™ Thin Film (K024199), a polymeric surgical mesh. This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of the requested data points (related to AI performance, sample sizes for AI training/testing, expert ground truth, MRMC studies, etc.) are not applicable to this submission.
However, I can extract the relevant information regarding the device's performance as presented in the submission.
1. Table of acceptance criteria and the reported device performance
The submission does not explicitly state quantitative "acceptance criteria" in the way one might for a diagnostic AI device (e.g., target specificity, sensitivity). Instead, the performance is demonstrated through studies showing the physical and biocompatible properties of the material, and its equivalence to a predicate device. The implicit acceptance criteria are that the device is biocompatible, biodegradable, and strong enough for its intended use, performing comparably to an already cleared device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of the materials used for this device. |
| Degradation/Resorbability | Degradation testing performed in a physiological buffered saline solution at 37 ℃ showed that the device is fully resorbable over a period of months. |
| Mechanical Strength (Suture Pullout) | OsteoBiologics performed suture pullout testing on a family of thin film products, which are identical in material composition. The results demonstrated that the films could withstand substantial loads and deformations before its physical integrity is compromised, therefore supporting the suitability of the IMMIX™ Thin Film for use in a clinical situation. |
| Substantial Equivalence to Predicate Device (MacroPore Surgi-Wrap (TS), K012025) | The IMMIX™ Thin Film is substantially equivalent in design, function and intended use to the MacroPore Surgi-Wrap (TS), cleared as K012025 on December 3, 2001. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an algorithm's performance. The studies mentioned are laboratory tests:
- Biocompatibility: No sample size specified, likely performed on material samples according to standard protocols for medical devices.
- Degradation testing: No sample size specified, likely performed on material samples.
- Suture pullout testing: Performed on "a family of thin film products," but specific sample sizes are not provided.
- Data Provenance: The studies were performed by OsteoBiologics (suture pullout, degradation) and an "independent certified laboratory" (biocompatibility). The origin of this data is therefore in-house/contracted lab testing, not human patient data, and it's inherently prospective (experimental testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical surgical mesh, not a diagnostic or AI-driven device requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable for the reasons stated above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
For the laboratory tests:
- Biocompatibility: Ground truth is established by standard biological assays and observation of cellular responses, as interpreted by expert toxicologists/biocompatibility specialists.
- Degradation: Ground truth is a direct measurement of material degradation over time under controlled conditions.
- Suture Pullout Testing: Ground truth is the direct measurement of force and deformation until failure using standardized mechanical testing equipment.
8. The sample size for the training set
Not applicable. There is no AI algorithm involved, and thus no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm involved, and thus no "training set."
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.